A combined pain competence and depression prevention training in inpatient multidisciplinary orthopaedic rehabilitation (Debora II)

A combined pain competence and depression prevention training in inpatient multidisciplinary orthopaedic rehabilitation (Debora II) - Debora 2

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

DRKS

Registry ID

DRKS00011302

Enrollment

216

Registered

2016-12-27

Start date

2017-01-09

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M51 M54 M53

Interventions

Group 1: control group: participants take part in a cognitive-behavioral pain competence training. It contains of four sessions each lasting one hour with a following workshop without trainer and refe

Eligibility

Sex/Gender

All

Age

20 Years to 65 Years

Inclusion criteria

Inclusion criteria: Men and women aged between 20 and 65 years; main diagnosis: chronic low back pain (ICD-10: M 51, M 53, M 54; = 6 months); voluntary participation with a written declaration of consent; knowledge of german language (the ability to read and write)

Exclusion criteria

Exclusion criteria: surgical operations in the musculoskeletal system; accidents within the last six months before the beginning of rehabilitation; somatic illnesses, which could be responsible for chronic low back pain (radicular symptoms, tumor, osteoporosis, inflammation, fibromyalgia); pregnancy, infections, cardiovascular diseases or metabolic diseases, which could complicate the rehabilitation; psychiatric diseases (anxiety disorder or depression, psychoses, post-traumatic stress disorder)

Design outcomes

Primary

Measure	Time frame
Standardised questionnaires are used to measure the primary and secondary outcome as well as sociodemographic data at the beginning of rehabilitation (t0), at the end of rehabilitation (t1) and 6 (t2) and 12 months (t3) after rehabilitation. primary outcome: - depressive symptoms (ADS) - anxiety (HADS) - somatisation (BSI-18) - symptoms of depression and anxiety (PHQ-4) - health-related quality of life (SF-12)	—

Measure

Time frame

Standardised questionnaires are used to measure the primary and secondary outcome as well as sociodemographic data at the beginning of rehabilitation (t0), at the end of rehabilitation (t1) and 6 (t2) and 12 months (t3) after rehabilitation. primary outcome: - depressive symptoms (ADS) - anxiety (HADS) - somatisation (BSI-18) - symptoms of depression and anxiety (PHQ-4) - health-related quality of life (SF-12)

—

Secondary

Measure	Time frame
Other important target parameters are: - pain-related parameters (e.g. pain-related questionnaire DGSS), - pain coping (FESV-BW), - pain-related cognition (AEQ), - generally and work-related load values (TICS and SPE), - subjective work ability (WAI).	—

Countries

Germany

Contacts

Public ContactAnne Köpnick

Europa-Universität Flensburg

anne.koepnick@uni-flensburg.de0461 805 30 21

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026